Desktop Health Announces that Flexcera™ Smile Ultra+ is now Available in Europe, Following Recent Class IIa MDR Certification by the European Union
October 04 2023 - 2:00AM
Business Wire
- Flexcera Smile Ultra+ is a next-generation nanoceramic resin
for 3D printing a wide range of permanent and temporary dental
restorations, including teeth for dentures, crowns, inlays, onlays,
bridges, veneers, as well as full, monolithic, and partial
dentures
- Users of Desktop Health, EnvisionTEC, and Carbon 3D printers
will be able to print Flexcera Smile Ultra+ on specified DLP
printing systems
- Desktop Health is launching a “Smile, Europe” campaign to
educate the dental community about the benefits of Flexcera resins,
such as same-day digital workflows and durable and customizable
digital designs that are easy to modify and reproduce
Desktop Health™, the trusted health care brand of Desktop Metal
(NYSE:DM), announced that its popular Flexcera™ Smile Ultra+ dental
resin, for 3D printing permanent and temporary restorations, is now
available for purchase in Europe following its successful
certification as a Class IIa medical device under the European
Union Medical Device Regulation (MDR).
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Desktop Health's Flexcera™ Smile Ultra+
dental resin for 3D printing permanent and temporary restorations
is now available for purchase in Europe following its successful
certification as a Class IIa medical device under the European
Union Medical Device Regulation (MDR). (Photo: Business Wire)
Flexcera Smile Ultra+ delivers exceptional strength, life-like
aesthetics, and the long-term performance expected from a permanent
restoration material. Already an FDA 510(k) Class II cleared
material, Flexcera Smile Ultra+ has been commercially available in
the United States since February 2022. The EU MDR certification
will expand access to the innovative material to more dental labs
and clinicians.
“Flexcera Smile Ultra+ has been a breakthrough 3D printing resin
for the dental community because of its life-like appearance and
exceptional performance,” said Lou Azzara, President of Desktop
Health. “Worldwide, the dental industry is going digital — moving
to intraoral scanners and digital manufacturing techniques that are
giving patients reliable, custom solutions fast, including same-day
production and delivery for many applications. Our premium Flexcera
material has become a preferred solution for clinicians and
patients in this environment, and we’re delighted to finally offer
it to our European labs, clinicians, and patients.”
Users of Desktop Health, EnvisionTEC, and Carbon brand DLP 3D
printers can purchase Flexcera Smile Ultra+ – starting today – in
tooth shades A1, A2, A3, A3.5, B1, and Bleach, through authorized
dealers.
To learn more about Flexcera Smile Ultra+ and the Flexcera
family of resins, visit TeamDM.com/Flexcera.
About Desktop Health
Desktop Health, a healthcare brand within the Desktop Metal
portfolio, delivers trusted additive manufacturing and material
technologies that improve patient lives. For 20+ years, Desktop
Health’s high-accuracy 3D printers and premium biocompatible
materials have produced regulatory-approved dental, medical, and
biofabrication solutions. For more on Desktop Health, visit
www.desktophealth.com
About Desktop Metal
Desktop Metal (NYSE:DM) is driving Additive Manufacturing 2.0, a
new era of on-demand, digital mass production of industrial,
medical, and consumer products. Our innovative 3D printers,
materials, and software deliver the speed, cost, and part quality
required for this transformation. We’re the original inventors and
world leaders of the 3D printing methods we believe will empower
this shift, binder jetting and digital light processing. Today, our
systems print metal, polymer, sand and other ceramics, as well as
foam and recycled wood. Manufacturers use our technology worldwide
to save time and money, reduce waste, increase flexibility, and
produce designs that solve the world’s toughest problems and enable
once-impossible innovations. Learn more about Desktop Metal and our
#TeamDM brands at www.desktopmetal.com.
Forward-looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. Forward-looking
statements generally are identified by the words “believe,”
“project,” “expect,” “anticipate,” “estimate,” “intend,”
“strategy,” “future,” “opportunity,” “plan,” “may,” “should,”
“will,” “would,” “will be,” “will continue,” “will likely result,”
and similar expressions. Forward-looking statements are
predictions, projections and other statements about future events
that are based on current expectations and assumptions and, as a
result, are subject to risks, uncertainties. Many factors could
cause actual future events to differ materially from the
forward-looking statements in this document, including but not
limited to, the risks and uncertainties set forth in Desktop Metal,
Inc.'s filings with the U.S. Securities and Exchange Commission.
These filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking statements.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and Desktop Metal, Inc. assumes no obligation and does
not intend to update or revise these forward-looking statements,
whether as a result of new information, future events, or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20231004075864/en/
Desktop Metal: Media Relations: Sarah Webster (724) 516-2336
Sarahwebster@desktopmetal.com
Investor Relations: Jay Gentzkow (781) 730-2110
jaygentzkow@desktopmetal.com
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